Critical Path Institute

“Lyle bootman and shaun kirkpatrick have a business relationship. Mike kasser and jeff jacob have a business relationship. Alan levin and peter corr have a business relationship.”

“Form 990 is prepared by an external cpa firm using information provided by the organization. The form is reviewed by the organization's comptroller, coo, president/ceo, an outside cpa, the board audit, finance, and risk committee, and the board of directors prior to being finalized.”

“All members of the board of directors and all officers of the organization are required to fill out a conflict of interest form annually. The results are compiled and reviewed by the board's audit, finance, and risk committee. Any actual or perceived conflicts that have the potential to bias any discussions or decisions by the board are discussed by the board. Any director with a real or potential conflict will recuse themselves from any discussion or decision where the conflict has a bearing.”

“A board of directors compensation committee meets and reviews executive compensation annually. Every few years the committee seeks an independent compensation consulting organization. After the consulting organization has been retained, the compensation committee receives the consultant's executive compensation reviews and recommendations. This information is then used as a basis for the compensation committee's recommendation to the board of directors. The last independent compensation survey was conducted for the ceo in august 2011. The ceo's salary has remained constant since the time of her hire. An overall salary program for employees must be approved by the board of directors compensation committee before implementation. All employee salary increases must be approved by the president/ceo.”

“Articles of incorporation can be found on the arizona corporation commission website. The conflict of interest policy and the financial statements (via the annual report) are posted on the institute's website.”

“The critical path institute (c-path) is an independent, non-profit organization uniquely dedicated to implementing the fda's critical path initiative by creating collaborations among regulators (scientists from the fda and ema) the regulated (medical product industry), academia, patients organizations, and other organizations that advance medical innovation through the development of tools and methods based upon sound, consensus based science. The accomplishments for this fiscal year report include: the coalition against major diseases develops tools and processes to accelerate progress in the prevention, treatment and cure of major neurodegenerative diseases, initially focusing on alzheimer's and parkinson's diseases. This year's accomplishments include: developed an informed consent form that will enable broader sharing of patient data and specimens for future research. Obtained regulatory endorsement of the statistical analysis approach for the hippocampal volume biomarker qualification effort. Received three letters of support from the fda encouraging the further study and use of cerebrospinal fluid analytes ab1-42, total-tau, and phospho-tau, and low baseline hippocampal volume measured by magnetic resonance imaging as exploratory prognostic biomarkers for enrichment in trials for ad; and molecular neuroimaging of the dopamine transporter as an exploratory prognostic biomarker for enrichment in trials for parkinson's disease. The coalition for accelerating standards and therapies is an initiative to accelerate clinical research and medical product development by creating and maintaining data standards, tools, and methods for conducting research in therapeutic areas that are important to public health. Cfast was initiated as a partnership between the clinical data interchange standards consortium (cdisc) and the critical path institute (c-path). The coalition has developed and published the following (22) cdisc therapeutic area standards: alzheimer's v1 and 2, asthma, breast cancer, cardiovascular, chronic hepatitis c, diabetes, dyslipidemia, influenza, multiple sclerosis, pain, parkinson's disease, polycystic kidney disease, qt studies, schizophrenia, tuberculosis v1 and v2, virology v1 and v2, traumatic brain injury, and chronic obstructive pulmonary disease (copd). A separate analysis data model (adam) supplement was published for diabetes. A new consortium entitled critical path for parkinson's was launched. Its goals are to develop quantitative model-based tools to accelerate the treatment of parkinson's disease, targeting patients at the first clinical signs of motor symptom onset. Their accomplishments this year include: received support from ema to proceed with qualification plan for molecular neuroimaging of the dopamine transporter as a prognostic biomarker for enrichment in trials for early parkinson's disease. Received a letter of support from the ema for the use of dat imaging as an enrichment biomarker for pd clinical trials. The mission of the critical path to tb drug regimens initiative is to accelerate the development of novel tb drug regimens that are safer, shorter in duration, and more efficacious than the current standard of care. Their mission expanded to also accelerate the development of a clinically useful in vitro rapid drug susceptibility assay to support tb regimen development and deployment. Their accomplishments this year include: the ema issued a positive qualification decision on cptr's qualified in vitro hollow fiber system model for tuberculosis. The who selected c-path to host tb clinical trials data platform. The reseqtb data platform launched for use by researchers, data contributors and consortia members. Tb-platform for aggregation of clinical tb studies launched. Delivered a quantitative model for time-to-positivity behavior using an integrated database of phase ii studies. Manufactured new sensititre plate containing current, new, and repurposed anti-tb drugs and shipped to multiple”

“The goal of the international neonatal consortium is to accelerate the development of safe and effective therapies for neonates. It engages the global neonatal community - families, neonatal nurses, academic scientists, regulators, pharmaceutical investigators, advocacy organizations, and funders - to focus on the needs of the neonate. Through teams that share data, knowledge, and expertise, the consortium will develop tools that can be incorporated into clinical trials for neonates. Their accomplishments this year include: held a face-to-face workshop in washington, dc, on to draft a white paper regarding consensus-based critical elements of clinical pharmacology studies in neonates which could be considered by regulators in preparation of future guidance documents, including recommendations for safer formulations encompassing ease of administration. Submitted comments on the notice of proposed rulemaking (nprm) "federal policy for the protection of human subjects" to the office for human research protections and supplied input on drugs and therapeutic areas that require further study in neonates in response to nichd's request for information on the best pharmaceuticals for children act priorities in pediatric therapeutics 2017. The goal of the polycystic kidney disease outcomes consortium is to develop and obtain regulatory qualification from the u.s. Food and drug administration (fda) and the european medicines agency (ema) of total kidney volume (tkv) as a prognostic biomarker for use in clinical trials for new therapies for autosomal dominant polycystic kidney disease (adpkd). After successfully accomplishing the primary goal, the consortium is now working on other regulatory challenges, clinical trial designs, exploratory endpoints, and the possibility of qualifying tkv as a surrogate endpoint. Their accomplishments for this year include: received a letter of support from the fda for the exploratory use of tkv in clinical trials for adpkd. Received a formal qualification of tkv as a prognostic biomarker from the fda in the form of a draft guidance (august, 2015) and from the ema as a qualification opinion (november, 2015). Held a very successful adpkd summit meeting with industry, academia, and international regulators to discuss potential solutions to address the need for better clinical endpoints for clinical trials of new therapies for adpkd. Formal qualification of tkv as a prognostic biomarker was received from the fda in the form of final guidance on september 15th, 2016. Tkv was accepted as a "reasonably likely surrogate" by the fda allowing it to be used in accelerated approval applications. The goal of the patient-reported outcome consortium is to establish and maintain a collaborative framework with appropriate stakeholders for the qualification of patient-reported outcome (pro) instruments and other clinical outcome assessment (coa) tools that will be publicly available for use in clinical trials where coa-based endpoints are used to support product labeling claims. Their accomplishments this year include: the following pro instruments are in various stages of the qualification process: for the asthma daily symptom diary, a quantitative pilot study was completed and quantitative pilot study report and quantitative data submitted to fda qrt for review. For the symptoms of major depressive disorder scale, a quantitative pilot study was completed and quantitative pilot study report and quantitative data was submitted to fda for review. For the functional dyspepsia symptom diary, the qualitative research was completed and qualitative research summary report is in development. For the three instruments for irritable bowel syndrome, the quantitative pilot study protocol and analysis plan was reviewed by fda, their suggestions were incorporated into the study documents, and a quantitative pilot study is being launched. For the non-small cell lung cancer symptom assessment questionnaire, the quantitative pilot study w”

“Research support services: program service expenses 1,405,309. Management and general expenses 0. Fundraising expenses 0. Total expenses 1,405,309. Consulting: program service expenses 1,027,701. Management and general expenses 37,144. Fundraising expenses 0. Total expenses 1,064,845. Other professional fees: program service expenses 924,300. Management and general expenses 13,390. Fundraising expenses 0. Total expenses 937,690.”